9,10-Anthracenedione, 1,4-diamino-, N,N'-mixed 2-ethylhexyl and hexyl and octyl derivs.

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from peer reviewed publication

Data source

Reference

Reference Type:

publication

Title:

Mutagenicity of the given test chemical in Ames' Salmonella Typhimurium Test

Author:

S. Venturini and M. Tamaro

Year:

1979

Bibliographic source:

Mutation Research

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

Bacterial gene mutation test was performed to evaluate the mutagenic response for the given test chemical.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

9,10-anthracenedione, 1,4-diamino-, N,N'-mixed 2-hydroxyethyl and methyl derivatives

EC Number:

219-604-2

EC Name:

9,10-anthracenedione, 1,4-diamino-, N,N'-mixed 2-hydroxyethyl and methyl derivatives

Cas Number:

2475-46-9

Molecular formula:

C17H16N2O3

IUPAC Name:

1-(2-hydroxyethylamino)-4-(methylamino)anthracene-9,10-dione

Details on test material:

- Name of test material: Blue F3R (C.I. disperse blue 3)
- IUPAC name: 9,10-Anthracenedione, 1,4-diamino-, N,N'-mixed 2-hydroxyethyl and methyl
- Molecular formula: C17H16N2O3
- Molecular weight: 296.324 g/mol

Method

Target gene:

Histidine

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA1535, TA100, TA1538 and TA98

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Cytokinesis block (if used):

No data

Metabolic activation:

with and without

Metabolic activation system:

S9 mix was prepared from liver homogenate of rats treated with Aroclor 1254 plus adequate cofactors

Test concentrations with justification for top dose:

100, 500 or 1000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test chemical was soluble in DMSO

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

ethylmethanesulphonate

methylmethanesulfonate

other: Hycanthone (TA1538 and TA98)

Details on test system and experimental conditions:

METHOD OF APPLICATION: soft-agar overlay method

DURATION
- Preincubation period: No data
- Exposure duration: No data
- Expression time (cells in growth medium): No data
- Selection time (if incubation with a selection agent): No data available
- Fixation time (start of exposure up to fixation or harvest of cells): No data available

SELECTION AGENT (mutation assays): No data available

SPINDLE INHIBITOR (cytogenetic assays): No data available

STAIN (for cytogenetic assays): No data available

NUMBER OF REPLICATIONS: 4 experiments were performed

NUMBER OF CELLS EVALUATED: No data available

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data available

OTHER EXAMINATIONS:
- Determination of polyploidy: No data available

- Determination of endoreplication: No data available

- Other: No data available

OTHER: No data available

Rationale for test conditions:

No data

Evaluation criteria:

The plates were observed for number of revertants/plate

Statistics:

No data

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA1535, TA100, TA1538, and TA98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

True negative controls validity:

not specified

Positive controls validity:

valid

Additional information on results:

No data

Remarks on result:

other: No mutagenic potential

Any other information on results incl. tables

Table: Mutagenic activity of Blue F3R (C.I. disperse blue 3)

Dose (µg/plate)	Number of His + revertants/plate
	TA1535		TA100		TA1538		TA98
	-	+	-	+	-	+	-	+
1000	1	3	7	10	8	4	18	21
500	1	2	10	10	7	4	18	18
100	1	1	12	9	4	4	15	16

 

Applicant's summary and conclusion

Conclusions:

The given test chemical did not induce reversion of mutation when applied to Salmonella typhimurium strains TA1535, TA100, TA1538, and TA98 in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.

Executive summary:

Bacterial gene mutation test was performed to evaluate the mutagenic response for the given test chemical The test was performed using Salmonella typhimurium strainsTA1535, TA100, TA1538, and TA98 in the presence and absence of S9 metabolic activation system. The test compound was dissolved in DMSO and used at dose levels of 100, 500 or 1000µg/plate. Concurrent positive control chemicals were also included in the study. The given test chemical did not induce reversion of mutation when applied to Salmonella typhimurium strains TA1535, TA100, TA1538, and TA98 in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.